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Vista phasor 408800, User Manual

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Appendix – Electromagnetic Compatibility and Electrical 

Safety Information

The PHASOR™ heated composite delivery system is tested according to IEC 60601-1-2, 

Edition 4.0. 

Medical electrical devices are subject to particular preventive action according to 

EMC rules and must be installed and operated according to the EMC guidelines in the 
accompanying documents.

Guidance and Manufacturer‘s Declaration – Electromagnetic Emission

The following tables are guidelines according to the 4th edition of the medical standard 

IEC 60601-1-2. 

PHASOR™ heated composite delivery system is intended for use in the electromagnetic 

environment specified below. The customer or the user of the PHASOR™ heated 
composite delivery system should assure that it is used in such an environment.

Guidance and Manufacturer‘s Declaration – Electromagnetic Immunity

The PHASOR™ heated composite delivery system is intended for use in the 

electromagnetic environment specified below. The customer or the user of the 
PHASOR™ heated composite delivery system should assure that it is used in such an 
environment.

PHASOR™

PHASOR™

PHASOR™

PHASOR™

PHASOR™

PHASOR™

PHASOR™

PHASOR™

Summary of Contents for phasor 408800

Page 1: ...ER S MANUAL For use by qualified professionals only 408800 408800 I V 77 ENG 2 Inter Med Inc 2200 South St Racine WI 53404 2500 U S A Tel 1 262 636 9755 Fax 1 262 636 9760 Toll Free 1 877 418 4782 www vista dental com Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands PatentPending Rx ONLY ...

Page 2: ...cle 7 Cleaning Disinfection 8 Infection Control Measures 9 Routine Maintenance 10 11 Battery Removal Replacement 12 Troubleshooting Guide 12 Technical Data 13 Symbol Identification 14 Battery Disposal 14 Safety Notes Warnings and Precautions 14 16 Operating Conditions and Safety Consideration 17 Heat Generation 17 Cool Down 17 Adverse Reactions 17 Contraindications 17 Vista Dental Products Terms a...

Page 3: ...HASOR is able to heat composite material to 150 F in seconds and maintain that temperature throughout the procedure Warming composite significantly lowers the viscosity of the material resulting in better adaptation reduced voids and microleakage and improved depth of cure Materials remain highly sculptable non sticky and easily shaped during manipulation The Vista Dental Products website www vist...

Page 4: ...spected upon arrival for evidence of shipping damage Damaged packaging may indicate the presence of an unsafe product and the product should not be used until carefully inspected If the package or product is damaged please contact Vista Dental Products at 877 418 4782 Toll Free as well as the delivery service to file a complaint Introduction Please reference the image below to familiarize yourself...

Page 5: ...tery when the indication lights are Red Charging the Battery The PHASOR battery is partially charged when shipped To charge the battery simply connect the micro USB charger to the USB charging port on the device handle and plug the power adapter into a standard outlet During battery charging the device activity indicator light will pulse Once charging is complete the device activity indicator will...

Page 6: ...TTING 2 SETTING 3 SETTING 4 3M DENTSPLY Ivoclar Kerr VOCO Coltene Kuraray GC Shofu Heraeus Kulzer Tokuyama OPTIMAL Setting Compatible Setting DO NOT USE CAUTION Parts of the composite compule may become hot Use caution and avoid touching the top of a hot composite compule CAUTION Do not deviate from the recommended settings Composite Setting Compatibility For a complete list of compatible compules...

Page 7: ... 1 2 3 4 Reference setting compatibility chart to determine the appropriate setting per composite brand CAUTION Do not deviate from the recommended settings Start Heating Cycle Short press to start stop heating cycle The blue lights will flash while heating Setting 1 3 45 seconds Setting 4 70 seconds The blue lights will turn solid when heating cycle is complete The device will automatically shut ...

Page 8: ...rformance CAUTION Always use a protective barrier The PHASOR is provided non sterile There are no special accessories needed to sterilize the PHASOR heated composite delivery system Quaternary ammonium compound products are recommended containing 20 alcohol or less Wipe do not spray solution onto the unit Prevent liquids from entering openings on the composite gun unit DO NOT AUTOCLAVE HANDPIECE R...

Page 9: ...ice by using diluted alcohol Store the device in the box if it is not to be used for an extended period of time Infection Control Measures CAUTION To prevent cross contamination a disposable plastic sleeve must be used over the PHASOR with each use A low density polyethylene plastic disposable barrier covers the nose cone of unit and provides a hermetically sealed barrier between the handpiece and...

Page 10: ...ll decrease performance 1 Insert the hex key provided into the trigger bolt 2 Rotate counterclockwise and remove the trigger bolt once loose 3 Slide the trigger and spring assembly apart from the device When reassembling ensure spring is inserted into the small opening in the trigger space ...

Page 11: ...removed from the device 6 Thoroughly clean the plunger space and LED lens to remove any composite residue NOTE Alcohol may be used as a cleaning solution DO NOT insert the brush past the end of the bristles 5 With the nosecone removed clean the device with the provided brush ...

Page 12: ...ate of composite 1 Inspect the USB charging port of any foreign objects that could interfere with a proper connection 2 Remove the battery and check orientation Reinsert into the device in proper orientation 3 Make sure the battery is properly inserted in the handpiece 4 Make sure the charger is plugged in and and verify the outlet is receiving power 1 Adjust flow setting to low or universal ramp ...

Page 13: ...Operating Conditions Operating Time Approximately 2 hrs fully charged Approximately 15 heat cycles on high setting Time to Charge Empty Battery Pack Approximately 3 hrs Classification Type BF Intermittent Operation The device has been designed solely for short term operation Temperature 10 C 40 C 59 F 104 F Atmospheric Pressure 697hPa 1013hPa 10 C 40 C Transport and Storage Conditions Temperature ...

Page 14: ...e BF Patient Applied Part Keep Dry Part Number Do not reuse Warning Caution Temperature Limitation Humidity Limitation Pressure Limitation Batch Code Lot Number European Representative Do not use if seal or packaging is compromised Autoclavable up to the temperature specified Consult instructions for use This symbol is a mandatory marking for devices entering the European market to indicate confor...

Page 15: ...elevated temperature from use in the PHASOR or other warming devices ONLY USE replacement batteries provided by the manufacturer ONLY DISPENSE composite after warming Not intended to dispense composite at room temperature or below The PHASOR composite gun is a medical device which is subject to IEC 60601 1 EN 60601 1 and EMC directives IEC 60601 1 2 EN 60601 1 2 Edition 4 0 as well as the 93 42 EE...

Page 16: ...has reached the ambient temperature Use only components and accessories listed in the instructions associated with the device Failure to do so will void the warranty may decrease the performance and may lead to unsafe operation In order to avoid electric shock do not introduce any objects into the device or remove the device enclosure Should you have any reason to suspect the safety of the device ...

Page 17: ...es not occur Cool Down PHASOR features a built in fan which will turn on automatically during operation The fan will remain on after operation until the device reaches a lower temperature Adverse Reactions There are no known adverse reactions Contraindications PHASOR should not be used for any application outside of composite resotrations DO NOT heat composite if it is already at an elevated tempe...

Page 18: ...rectly from the manufacturer for shipping instructions a return authorization number and ARS shipping label There is no warranty remedy or condition expressed or implied except as provided herein The warranty and remedies contained herein are made by the manufacturer to the first buyer for dental use and are in lieu of all other agreements expressed or implied liabilities or remedies for breach of...

Page 19: ...ate Return Restocking Policy Any equipment returned within 30 days from the date of the original shipment from Vista Dental Products may not be assessed a restocking fee as long as the merchandise has current labeling and unopened non soiled packaging Unopened equipment returned within 31 60 days from the date of the original shipment from Vista Dental Products requires a restocking fee of 25 of t...

Page 20: ...according to the 4th edition of the medical standard IEC 60601 1 2 PHASOR heated composite delivery system is intended for use in the electromagnetic environment specified below The customer or the user of the PHASOR heated composite delivery system should assure that it is used in such an environment Guidance and Manufacturer s Declaration Electromagnetic Immunity The PHASOR heated composite deli...

Page 21: ...from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broad cast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Val...

Page 22: ...F communications equipment and the Phasor Heated Composite Delivery System The PHASOR heated composite delivery system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PHASOR heated composite delivery system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobi...

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